Orchestra BioMed said today that it received breakthrough device designation from the FDA for its Virtue sirolimus-eluting balloon for the treatment of below-the-knee peripheral artery disease.
The Virtue SEB is the first and only non-coated below-the-knee sirolimus-eluting angioplasty balloon system to receive a breakthrough nod, Orchestra BioMed said in a release.
Get the full story at our sister site, Drug Delivery Business News.
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